Simvastatin Tablets — Class II drug recall D-1234-2020
Terminated recall by Aurobindo Pharma USA Inc., reported 2020-04-22, distributed nationwide. CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
| Recall number | D-1234-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2020-03-18 |
| Classified | 2020-04-13 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2024-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 26,976 units |
| Reason classes | cgmp, packaging |
| NDC | 65862-0050, 65862-0050-00, 65862-0050-01, 65862-0050-26, 65862-0050-30, 65862-0050-45, 65862-0050-90, 65862-0050-99, 65862-0051, 65862-0051-00, 65862-0051-01, 65862-0051-26, 65862-0051-30, 65862-0051-45, 65862-0051-90, 65862-0051-99, 65862-0052, 65862-0052-00, 65862-0052-01, 65862-0052-26, 65862-0052-30, 65862-0052-45, 65862-0052-90, 65862-0052-99, 65862-0053 and 14 more |
| Lot numbers | 05319004A1 |
| Expiration dates | 2022-03 |
Product
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1234-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.